Pharma Focus Asia

RedHill's Aemcolo® Granted FDA QIDP 5-Year Exclusivity Extension

Tuesday, December 06, 2022

RedHill Biopharma Ltd., a specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration's (FDA) Exclusivity Board has granted Aemcolo®2 five years' exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years' data exclusivity granted as a new chemical entity (NCE) for the treatment of travelers' diarrhea (TD) caused by non-invasive strains of Escherichia coli (E. coli) in adults.

Patricia Anderson, RedHill's Senior Vice President of Regulatory Affairs said: "Given the great concerns around maintaining effective therapeutic options for infectious diseases in the face of growing microbial resistance, Aemcolo represents an important innovation to meet significant unmet need. This FDA grant of five additional years' exclusivity for Aemcolo under the FDA's Generating Antibiotic Incentives Now (GAIN) Act Qualified Infectious Disease Product (QIDP) designation, in addition to the five years awarded to Aemcolo based on new chemical entity exclusivity, will protect that innovation through to 2028."

Aemcolo, containing 194 mg of rifamycin as delayed-release tablets, is an orally-administered, non-systemic antibiotic employing MMX® technology, a proprietary drug delivery system that distributes rifamycin in a controlled manner to the lower intestine. Due to its non-systemic delivery, Aemcolo is associated with limited side effects and minimal potential for interactions with other medications.

Aemcolo is listed as an acute diarrhea antibiotic treatment recommendation in the Centers for Disease Control and Prevention (CDC) Yellow Book1.

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